Skip to content

Offset reamer handle - Dual coupling transmission (NC)

by Incipio Devices SA

Ref 50244522

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07630055306005 UDI-DI Date28 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number7630055300502445ORHBT Basic UDI-DI 07630055306005UDI-DIDate23 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Surgical power tool adaptor
Model / Ref / Catalog
50244522
Primary DI / UDI-DI
07630055306005
Basic UDI-DI
7630055300502445ORHBT
Direct Marketing DI
07630055306005
FDA Product Code
LXH
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Surgical power tool adaptor
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000030518
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Incipio Devices SA

See all devices from Incipio Devices SA →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No